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Sustained-release nepafenac eye-drops preparation

A technology for nepafenac and ophthalmic preparations, applied in the field of ophthalmic pharmaceutical preparations, can solve problems such as not yet on the market, and achieve the effects of high intraocular bioavailability, strong penetration and low cost

Inactive Publication Date: 2015-04-08
SANMING XINMAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Alcon (China) Ophthalmic Products Co., Ltd. has been approved to apply for clinical registration of nepafenac eye drops in China (clinical approval), but it has not yet been launched

Method used

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  • Sustained-release nepafenac eye-drops preparation
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Embodiment Construction

[0021] A sustained-release nepafenac ophthalmic preparation, comprising nepafenac, safflower flavin, polycarbophil, polysorbate, auxiliary materials and water for injection; the dosage form of the ophthalmic preparation is eye drops, Ophthalmic gel, ophthalmic ointment or any pharmaceutical dosage form suitable for topical ophthalmic application.

[0022] When the dosage form of the ophthalmic preparation is eye drops, the weight ratio is nepafenac: safflower flavin: polycarbophil: polysorbate: auxiliary material=1:1:0.5~2:0.05~0.2: 0.102-1.5, the mass fraction of nepafenac is 0.1%-1%, that is, the content of nepafenac is 0.1-1 part by weight per 100 parts by weight of the ophthalmic preparation.

[0023] The auxiliary material includes a bacteriostatic agent and a thickener, and the pH value of the eye drop is 5.5 to 7.5, and the osmolality of the eye drop is 250 to 350mOsmol / kg; the bacteriostatic agent is thimerosal, quaternary Any combination of one or more of ammonium sa...

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Abstract

A sustained-release nepafenac eye-drops preparation includes nepafenac, safflower yellow, polycarbophil, polysorbate and accessories in the weight ratio of 1:1:0.5-2:0.05-0.2:0.102-1.5 or 0.502-5.5, and further comprises water for injection, wherein the mass fraction of nepafenac is 0.1%-1%. The sustained-release nepafenac eye-drops preparation can also include nepafenac, safflower yellow, polycarbophil, polysorbate, anhydrous lanolin, liquid paraffin and yellow vaseline in the weight ratio of 1:1:0.5-2:0.05-0.2:8-15:2-10:75-95. The invention has the advantages of good intraocular penetration, high intraocular bioavailability, strong penetration, strong targeting effect, and little toxic and side effect.

Description

technical field [0001] The invention relates to an ophthalmic pharmaceutical preparation for treating non-infectious inflammation, in particular to a slow-release nepafenac ophthalmic preparation. Background technique [0002] The clinical application of non-steroidal antiinflammatory drugs (NSAIDS) has a history of nearly one hundred years. Since the widespread use of glucocorticoids in clinical practice, the application of such drugs has once decreased. However, because glucocorticoids can cause dependence, the drug cannot be stopped immediately in the short term, and long-term drug use can cause many serious adverse reactions, so the research on NSAIDS has been re-emphasized. In recent decades, antihistamines, anticongestants, mast cell stabilizers, corticosteroids and other drugs have been used clinically to treat eye allergies and other diseases. Due to the serious adverse reactions of the above drugs, non-steroidal anti-inflammatory Drugs have anti-inflammatory, anti-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/351A61K9/08A61K9/06A61K47/34A61K47/32A61P29/00A61P27/02A61K31/165
Inventor 张屹峰王延东
Owner SANMING XINMAO PHARMA
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